Effect of Qizhitongluo capsule on lower limb rehabilitation after stroke: A randomized clinical trial.

Autor: Yu Y; Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, No.16 Nanxiaojie, Dongzhimen nei, Beijing, 100700, China., Tang L; Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital, the 5th Zip, Hai Yun Cang, Beijing, 100700, China., Cui F; Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital, the 5th Zip, Hai Yun Cang, Beijing, 100700, China., Jiao F; Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, No. 60 Huanghe North Street, Shenyang, 110034 Liaoning, China., Zhang D; Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, No. 60 Huanghe North Street, Shenyang, 110034 Liaoning, China., Ma J; Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, No. 60 Huanghe North Street, Shenyang, 110034 Liaoning, China., Ding W; Southern District of Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No.138, Section 2, Xingfeng Street, Beijing, 100191, China., Yu Y; Southern District of Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No.138, Section 2, Xingfeng Street, Beijing, 100191, China., Zhang B; Southern District of Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No.138, Section 2, Xingfeng Street, Beijing, 100191, China., Meng Z; First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, No. 314 Anshan West Road, Tianjin, 300193, China., Dai X; First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, No. 314 Anshan West Road, Tianjin, 300193, China., Liu D; Langfang Traditional Chinese Medicine Hospital, No. 108 Yinhe North Road, Guangyang District, Langfang, 462000 Hebei, China., Chang J; Langfang Traditional Chinese Medicine Hospital, No. 108 Yinhe North Road, Guangyang District, Langfang, 462000 Hebei, China., Qu Y; Sichuan University West China Hospital, No.17, Section 3, Renmin South Road, Chengdu, 610041 Sichuan, China., Li Y; Sichuan University West China Hospital, No.17, Section 3, Renmin South Road, Chengdu, 610041 Sichuan, China., Wang H; Sichuan University West China Hospital, No.17, Section 3, Renmin South Road, Chengdu, 610041 Sichuan, China., Wang X; First Affiliated Hospital of Henan University of Traditional Chinese Medicine, No. 19 Renmin Road, Zhengzhou, 450000 Henan, China., Liu X; First Affiliated Hospital of Henan University of Traditional Chinese Medicine, No. 19 Renmin Road, Zhengzhou, 450000 Henan, China., Zhou H; First Affiliated Hospital of Henan University of Traditional Chinese Medicine, No. 19 Renmin Road, Zhengzhou, 450000 Henan, China., Zhao J; The Affiliated Hospital to Changchun University of Traditional Chinese Medicine, No. 147 Gongnongda Road, Changchun, 130021 Jilin, China., Wang Y; The Affiliated Hospital to Changchun University of Traditional Chinese Medicine, No. 147 Gongnongda Road, Changchun, 130021 Jilin, China., Zhang Y; The Affiliated Hospital to Changchun University of Traditional Chinese Medicine, No. 147 Gongnongda Road, Changchun, 130021 Jilin, China., Ma Q; Affiliated Zhongshan Hospital of Dalian University, No. 6 Jiefang Street, Dalian, 116001 Liaoning, China., Liu K; Affiliated Zhongshan Hospital of Dalian University, No. 6 Jiefang Street, Dalian, 116001 Liaoning, China., Liang J; Affiliated Zhongshan Hospital of Dalian University, No. 6 Jiefang Street, Dalian, 116001 Liaoning, China., Lu Y; Teaching Hospital of Chengdu University of Traditional Chinese Medicine, No. 9 Twelfth Bridge Road, Chengdu, 610072 Sichuan, China., Xiaomin Y; Teaching Hospital of Chengdu University of Traditional Chinese Medicine, No. 9 Twelfth Bridge Road, Chengdu, 610072 Sichuan, China., Song Y; Luohe Hospital of Chinese Medicine, No. 649 Jiao Tong Road, Luohe, 462000 Henan, China., Guo E; Luohe Hospital of Chinese Medicine, No. 649 Jiao Tong Road, Luohe, 462000 Henan, China., Li X; Luohe Hospital of Chinese Medicine, No. 649 Jiao Tong Road, Luohe, 462000 Henan, China., Yang Q; Luohe Hospital of Chinese Medicine, No. 649 Jiao Tong Road, Luohe, 462000 Henan, China., Huang L; First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine, No. 89-9 Dongge Road, Nanning, 530023 Guangxi Zhuang Autonomous Region, China., Wu P; First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine, No. 89-9 Dongge Road, Nanning, 530023 Guangxi Zhuang Autonomous Region, China., Wang J; Weifang Hospital of Traditional Chinese Medicine, No. 1055 Weizhou Road, Weifang, 26104 Shandong, China., Liu J; Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, No.16 Nanxiaojie, Dongzhimen nei, Beijing, 100700, China., Li B; Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, No.16 Nanxiaojie, Dongzhimen nei, Beijing, 100700, China., Chen B; School of Public Health, Southeast University, Dijia Qiao 87, Nanjing, 210009 Jiangsu, China., Chen Q; School of Public Health, Southeast University, Dijia Qiao 87, Nanjing, 210009 Jiangsu, China., Yue Q; School of Public Health, Southeast University, Dijia Qiao 87, Nanjing, 210009 Jiangsu, China., Xie Y; Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital, the 5th Zip, Hai Yun Cang, Beijing, 100700, China. Electronic address: xyz_3191@aliyun.com.cn., Wang Y; Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, No.16 Nanxiaojie, Dongzhimen nei, Beijing, 100700, China. Electronic address: wangyongyan2010@sina.cn., Wang Z; Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, No.16 Nanxiaojie, Dongzhimen nei, Beijing, 100700, China. Electronic address: zhonw@vip.sina.com.
Jazyk: angličtina
Zdroj: Pharmacological research [Pharmacol Res] 2021 Mar; Vol. 165, pp. 105464. Date of Electronic Publication: 2021 Jan 27.
DOI: 10.1016/j.phrs.2021.105464
Abstrakt: Background: An individual's level of lower limb motor function is associated with his or her disability level after stroke, and motor improvement may lead to a better prognosis and quality of life. Data from animal models show that Qizhitongluo (QZTL) capsule facilitates recovery after focal brain injury. We aimed to validate the efficacy and safety of the QZTL capsule for promoting lower limb motor recovery in poststroke patients.
Methods: In this randomized, multicenter, double-blind, placebo- and active-controlled trial from 13 sites in China, participants with ischemic stroke and Fugl-Meyer motor scale (FMMS) scores of <95 were eligible for inclusion. Patients were randomly assigned in a 2:1:1 ratio to the QZTL group, Naoxintong (NXT) group or placebo group for 12 weeks at 15-28 days after the onset of stroke. The primary outcome was the change in the Lower Limb FMMS (FMMS-LL) score from baseline over the 12-week intervention period.
Results: 622 participants were randomly assigned to the QZTL group (309), NXT group (159), or placebo group (154). The FMMS-LL score increased by 4.81 points (95 % CI, 4.27-5.35) in the QZTL group, by 3.77 points (95 % CI, 3.03-4.51) in the NXT group and by 3.00 points (95 % CI, 3.03-4.51) in the placebo group at week 12. The QZTL group showed significantly larger improvements compared with the placebo group at each interview from weeks 4-12 (difference, 0.89 [0.30,1.49] at week 4, P = 0.0032; difference, 1.83[1.01,2.66] at 90 days poststroke, P < 0.0001; difference, 1.81[0.88,2.74] at week 12, P = 0.0001).
Conclusion: The QZTL capsule is an effective treatment for lower limb motor impairment. The finding indicates that the QZTL capsule may be used as a potential new strategy for stroke rehabilitation.
(Copyright © 2021. Published by Elsevier Ltd.)
Databáze: MEDLINE
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